Patient Sex in Prescribing CGRP Receptor Antagonists for Migraine —Reply

In Reply We thank Lanteri-Minet et al for commenting on our recently published Viewpoint in JAMA Neurology addressing sex differences in outcomes of calcitonin gene-related peptide (CGRP) receptor antagonists in migraine treatment. As noted in their letter, our perspective was based on pooled pivotal trial data analysis obtained from published US Food and Drug Administration (FDA) reviews submitted by pharmaceutical sponsors that showed that there was no therapeutic gain in the male population for acute migraine treatment with either ubrogepant or rimegepant. We were pleased that the authors noted that our conclusions were consistent with a body of experimental animal and human data showing that the effects of CGRP may be sexually dysmorphic. The authors go on to state that such a sexual dysmorphism implies that the influence of gender should affect both gepants and monoclonal antibodies (CGRP-mAbs) targeting CGRP and that discussion on CGRP-mAbs data is absent from our Viewpoint, followed by discussion of data that do not identify sex as a variable in the outcomes of clinical trials with CGRP-mAbs in the real world.
Source: JAMA Neurology - Category: Neurology Source Type: research